Job Description
Job Title: Quality Assurance Specialist III / Data Integrity Compliance Officer
Last Review Date: 04Jan2021
Summary
Supports the organization with compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Facilitates internal training on quality assurance/data integrity requirements, processes, and procedures. Supports the organization with responsibility for creating training materials, delivery of training to staff, proactively fostering a culture of Data Integrity, and resolving Data Management issues.
Essential Functions
Assures compliance with cGMP regulations, Thermo Fisher standards, and applicable regulatory requirements. Resolves Quality Assurance issues complex in scope following cGMP regulations and Thermo Fisher standards. Drives improvement of processes of the quality system. Authors, revises, reviews, and approves controlled documents in compliance with cGMP regulations. Performs assigned tasks and work to achieve company goals and department objectives. Tracks and/or manages Corrective and Preventative Action (CAPA) system. Assists in customer and/or regulatory audits. Establishes and chairs the Data Integrity Governance Team meetings. Provides assessments and status updates to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity. Communicates regularly with site and above-site Data Integrity teams. Communicates actions, compliance gaps, and commitments to respective areas, including senior site management and corporate. Maintains and reports Data Integrity metrics as assigned. Ensures all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations. Establishes and leads a surveillance program to audit all CGxP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures. All other tasks as assigned for Specialist II or Specialist III duties.
Education
Bachelor's degree required in physical science, chemistry or related field.
Experience
Ideal experience includes at least 5 years of Quality Systems/Assurance experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems.
Equivalency
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies

• Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
• Experience in data review, 21 CFR Part 11 instrumentation compliance.
• Knowledgeable in Quality Management Systems (FDA or ICH approach to risk management and QMS). Demonstrated ability to write and provide a thorough QA technical review of root cause investigations, OOS, and complaints.
• Ability to audit GxP processes and Quality Management Systems.
• Experience with review of CAPA reports, Master Batch Records, SOPs, change control, validation protocols and reports, QA agreements, and audit reports.
• Experience in regulatory inspections, if applicable.
• Ability to assess Quality System related procedures for their effectiveness and make improvements, as necessary.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Effective written, interpersonal, and presentation skills.
• Ability to work on multiple projects simultaneously.

Physical Requirements
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Disclaimer
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Benefits:
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
EEO/Reasonable Accommodation:
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.